The Homeogenomic Trial

NCT02018341 | Withdrawn

• 1 other identifier: 44817
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized double-blind placebo controlled homeopathic pathogenetic trial (HPT) will be carried out on 30 healthy adult volunteers. The remedy used for the proving will be administered in a potency of 30C. The remedy being used is a common homeopathic remedy commercially available in the US, but the exact remedy is not disclosed to participants.The purpose of the proving is twofold: 1) to determine if there is a difference in symptoms between those receiving an active versus placebo medicine, and 2) to see if there is a difference in gene expression between those who receive the homeopathic remedy or placebo. It is hypothesized that participants receiving the active medication will have more symptoms characteristic of the remedy and have specific patterns of gene expression in whole blood that are different from those in placebo recipients. Participants will record symptoms in a diary for 3 days prior to administration of study medications, during 3 day of its administration and for 3 days following completion of the study medication. Blood will be drawn for gene expression studies on the day that the study medication is started and again after taking the study medication for approximately 48 hours. An additional, optional blood draw for possible future analysis of gene expression will be done at the end of the study period.

Conditions

Healthy

Keywords

Assessment of biologic activity of a homeopathic remedy

Outcome Measures

Primary Outcomes (2)

• Characteristic symptoms

  Symptoms that occur in participants that are characteristic of the homeopathic remedy being used in the study

  6 days

• gene expression

  Changes in whole blood gene expression from just prior to beginning study medication until 48 hours after beginning study medication

  2 days

Secondary Outcomes (1)

• gene expression in sensitive provers

  2 days

Study Arms (2)

homeopathic remedy in 30C potency

EXPERIMENTAL

5 lactose globules containing a commonly used homeopathic remedy in the potency of 30C will be administered twice daily for 3 days

Other: homeopathic remedy in 30C potency

placebo

PLACEBO COMPARATOR

5 lactose globules without any homeopathic remedy will be administered twice daily for 3 days

Other: Placebo

Interventions

homeopathic remedy in 30C potency OTHER

homeopathic remedy in 30C potency

Placebo OTHER

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Read and Speak English

You may not qualify if:

• Acute illness in last 7 days
• Chronic illness requiring daily medication
• Use of homeopathic remedy within 4 weeks
• Use of homeopathic remedy of 200C potency in past 2 months
• Women who are pregnant or breastfeeding an infant

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Bastyr University

Kenmore, Washington, 98028, United States

Location

MeSH Terms

Interventions

Homeopathy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• James A Taylor, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: December 23, 2013
• Study Start: June 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: February 1, 2014
• Last Updated: December 23, 2013

Record last verified: 2013-12

Locations

US (1)